iVeena announces the commencement of a 36 patient Phase I/2a pilot clinical study for the treatment of Keratoconus (IVMED-80). The Company has Orphan Drug Designation for this product.

iVeena announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for IVMED-80, for the treatment of keratoconus. Keratoconus is a degenerative disorder causing a cornea to become conical in shape that can seriously distort vision. This may lead to a corneal transplant. IVMED-80 is the first eye-drop, non-surgical, non-laser treatment for medical crosslinking of the cornea.

iVeena Completes Phase 1/2a Pilot Clinical Study for IVMED-10, a Bioerodable, Sustained Release, Intracapsular Implant that Delivers Dexamethasone to Both Anterior and Posterior Eye Segments to Treat Inflammation and Pain Associated with Cataract Surgery.

"iVeena is pleased to receive a total of $450K in Federal Government grants to advance its portfolio programs," said Gerald Simmons, CEO. "$225K is an NIH grant for its Keratoconus Orphan Drug candidate. IVMED-80 is the first eye-drop, non-surgical, non-laser treatment for medical crosslinking of the cornea. $225K is an NSF grant for iVeena’s Gene Therapy program for various ophthalmic applications.”

On Monday, May 30th, iVeena initiated the Phase I/2a pilot clinical study for IVMED-10. This product is a bioerodable dexamethasone implant given at the time of cataract surgery that releases the drug in the lens capsule over an approximate two week period. “This product is designed to eliminate the need for daily administration of a steroid and an NSAID that published reports show is highly confusing and difficult for a significant portion of the older target population that under go cataract surgery," said Jerry Simmons, CEO. The market for post surgery cataract drops exceeds $1B annually. Results of the study should be available late July or early August, this year.

iVeena to present at the BioTech Showcase Conference that runs in parallel with the JP Morgan Conference in San Francisco on Wednesday, January 11, 2017

Glaucoma affects approximately three million individuals in the US and can lead to blindness if not treated. The current standard of care is to administer eye drops on a daily basis that results in a high level of patient non-compliance and the resulting series side effects. The first MIGS device to eliminate the need for eye drops was recently approved. iVeena has developed what we consider is an improved product (increased aqueous outflow) compared to the currently marked products. “The USTAR TAP grant will allow iVeena to accelerate its pre-clinical development of this product and improve our chances of moving forward to clinical studies" said Jerry Simmons, CEO.